Workflow Validation of an In-home Auto-titrating Mandibular Positioner

Obstructive Sleep Apnea Clinical Trial

Official title:

Workflow Validation of an In-home Auto-titrating Mandibular Positioner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933112
• Other study ID #: ZCP2015_02
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: October 11, 2018

Study information

• Verified date: October 2018
• Source: Zephyr Sleep Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

Description:

One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 11, 2018
• Est. primary completion date: September 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Minimum 18 years of age

2. Participant has been deemed suitable for oral appliance therapy

3. Prescription for oral appliance

4. Adequate range of motion

5. Adequate dentition

6. Ability to understand and provide informed consent

7. Ability and willingness to meet the required schedule

Exclusion Criteria:

1. Loose teeth or advanced periodontal disease

2. Full dentures or dental implants

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Auto-titrating mandibular positioner test
Participants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test.

Locations

Country	Name	City	State
United States	Premier Sleep	Bellevue	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Zephyr Sleep Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Integration of the device into the existing workflow of a dental sleep medicine practice	Data for this outcome are largely directed at the study staff, not study participants. Data collected for this outcome include: time required to evaluate eligibility for device use, prepare device for use, and ease of scheduling of study visits	1 year
Primary	Convenience and feasibility of carrying out a multi-night AMP study in the home	Participants will complete a questionnaire following their AMP tests to collect data on ease of use of the device and opinion of the various device components.	1 year
Primary	Feasibility of instructing the participant on the use of the AMP device at the practitioner's office	Data for this outcome are directed at study staff, not study participants. Data collected will include feedback on ease of training participants on device use. Participants will be asked if they felt they received adequate training from the study staff via a questionnaire.	1 year
Secondary	Time to treatment	Time to treatment will be evaluated by tracking the time from the first consultation at the dentist's office to the setting of the temporary appliance (for individuals whose tests indicate they are predicted candidates for oral appliance therapy).	1 year
Secondary	Number of study visits	The number of study visits will be recorded. This data will be collected from study records and does not require input from the participant.	1 year
Secondary	Length of study visits	The length of each visit (minutes) will be recorded. This data will be collected from study records and does not require input from the participant.	1 year